Director Biopsy/Needle Guide/Probe Cover Kit 4218
by Protek Medical Products, Inc.
Ref 1-535-4218
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084191215000STNE 00841912101115 | Date15 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00841912101115 | Date25 Apr 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- aspen surgical® EUDAMEDDirector Biopsy/Needle Guide/Probe Cover Kit GUDID
- Generic Name
- Needle guide, single-use
- Device Name
- Needle Guides (sterile)
- Model / Ref / Catalog
- 1-535-4218 EUDAMED4218 GUDID
- Primary DI / UDI-DI
- 00841912101115
- Basic UDI-DI
- 084191215000STNE
- FDA Product Code
- KKX, ITX
- EMDN Code
- A018002 Needle guides
- GMDN Term
- Needle guide, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 878.4370, 892.1570
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 1-535-4218 | 4218 |
| Device Class | Class I | Class II |
Other devices from Protek Medical Products, Inc.
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No